GenoMed announced today that it has filed a patent application on two genes linked to common cancers. These are the first new disease genes the company has filed on since its multiple patent applications on ACE, a "master" disease gene.

The first gene, involved in copying DNA, was linked specifically to pancreatic and ovarian cancers, which are notoriously hard to diagnose at an early stage. It could help in the early diagnosis of patients at high risk for these cancers, as well as serve as a possible drug target for treatment of these poorly treatable diseases.

The second gene codes for a scaffolding protein involved in building protein networks inside the cell. It was linked to all six common cancers (lung, colon, breast, prostate, ovarian, and pancreatic), and may lead to new broad-spectrum chemotherapeutic agents.

Although an FDA advisory panel voted 20-3 Friday to recommend against allowing Merck to sell over-the-counter (OTC) Mevacor, a cholesterol-lowering statin drug, Bristol-Myers Squibb is seeking approval of a 20-milligram OTC version of Pravachol. "We are continuing a robust program to provide the FDA with the information it needs," company spokesman Rob Hutchison says. "Our own studies are underway." Panel members said Merck’s "actual use" study, which simulated pharmacies selling OTC Mevacor, failed to show that consumers could properly decide on their own whether to take the statin.

Nearly six out of 10 study participants who used OTC Mevacor still ended up consulting a doctor. And even so, nine out of 10 failed to meet at least one of the criteria set forth on the drug’s label.

By switching a drug to OTC status, manufacturers hope to boost sagging sales resulting from generic competition. When a drug is switched, its manufacturer gets exclusive rights to sell it OTC for three years. Prescription Mevacor already is off patent, so it faces competition from generic lovastatin. Pravachol’s patent expires in April 2006. OTC Mevacor would have been the first non-prescription drug to treat a symptomless chronic condition. The FDA has until Feb. 24 to reach a decision about OTC Mevacor.

St. Jude Medical settled a 2000 patent infringement suit with heart-valve technology company Edwards Lifesciences Corp. Edwards will receive a $5.5 million payment, and St. Jude Medical will get paid-up licenses for certain of its heart valve therapy products.

In the suit, Edwards claimed St. Jude Medical infringed on three of Edwards’ patents, two relating to annuloplasty rings and one relating to manufacturing methods used to make tissue heart valves.

Force Field Wireless claims to have developed a solution to the international menace of marauding geek wardrivers – DefendAir paint "laced with copper and aluminum fibers that form an electromagnetic shield, blocking most radio waves and protecting wireless networks". According to a South Florida Sun Sentinel article, one coat of the water-based paint "shields Wi-Fi, WiMax and Bluetooth networks operating at frequencies from 100 megahertz to 2.4 gigahertz", while two or three applications are "good for networks operating at up to five gigahertz".

There are some downsides as Force Field Wireless admits that "radio waves find leaks" andthe company asks users to be aware that the product "must be applied selectively" otherwise it "might hinder the performance of radios, televisions and cell phones". Although DefendAir is available only in grey, it can be used as a primer, so those who require wireless peace of mind plus bold fashion statement can cover it up quite nicely. And I thought the aluminum foil I have all over my house would be enough. Hmmmmm.

Amgen Inc. has added a warning to its anemia drug Aranesp after studies showed high doses of similar drugs can cause blood clots and death. Aranesp is widely used to treat anemia in adult cancer patients as well as chronic kidney disease. Some researchers had thought elevating hemoglobin might boost the effectiveness of chemotherapy and radiation to fight cancer. The company said in a Jan. 11 letter to health professionals that two clinical studies revealed the complications when similar drugs were used to raise hemoglobin levels above recommended levels. A Food and Drug Administration panel of outside experts last year called for more study of the risks of the anemia drugs, including faster tumor growth and more blood clots. The company said it would not change its dosage recommendations. Story here.

InPharma reported that the European Commission, the biotech industry and Chinese government are funding a project aimed at safety in nanobiotechnology. As Philips and GE Healthcare are working on the development of nanomaterials for use in patients, a portion of the $15.6 million will be directed towards studies of the in vitro and in vivo toxicology of nanomaterials, and also whether the size of the particles affects their toxicity, in the same way that asbestos is safe when encountered in a sheet, but causes cancer when inhaled as a dust.

Last year, one study was reported showing that inhaled nano-sized particles accumulate in the nasal cavities, lungs and brains of rats, raising concerns that this build-up could lead to harmful inflammation and a risk of brain damage or other central nervous system disorders. And it is known that carbon “buckyballs,” a spherical form of the element that has properties attractive for drug delivery, are toxic to cells. See the article here.

The World Intellectual Property Organization (WIPO) marked the filing of the one millionth international patent application under the Patent Cooperation Treaty (PCT) in the 26-year history of the PCT. The Director General observed "While it took 22 years to receive the first half million PCT patent applications, it took only 4 years to top the one million mark, reflecting an astonishing acceleration in the pace of technological development and unprecedented use of the international patent system." The PCT facilitates the process of obtaining patent protection in more than 120 countries through the filing of a single international application.

The largest users of the PCT system have originated from the United States of America, Japan, Germany, the UK and France. That said, the numbers of PCT applications from several developing country members continue to show a marked increase, most notably in India and the Republic of Korea which enjoyed double-digit growth in 2003.

The inventor of an LED technology has reluctantly agreed to a record settlement from his former employer in a dispute. Shuji Nakamura, now a professor at the University of California, Santa Barbara, will receive 840 million yen ($8.1 million) from his former employer, the Nichia Corporation, for inventing blue-light-emitting diodes. Nichia secured lucrative patents for Mr. Nakamura’s invention, which allowed the creation of more vibrant video billboards and traffic signal lights and helped lead to the development of blue lasers, which are used in the latest DVD players. His invention was also useful in creating white-light-emitting diodes, which may someday replace incandescent bulbs as a source of indoor lighting.

The case goes against the tradition that employees should sacrifice everything for their companies. Traditionally, in Japan, corporate engineers and scientists are treated just like less-skilled employees. It is unusual for Japanese companies to sign contracts with their researchers that specify how profits from their inventions will be shared, as is often the practice in American companies.

The amount of the settlement was significantly smaller than the $190 million the Tokyo District Court awarded inventor Shuji Nakamura in January as reasonable compensation.

By mandating that employee-inventors receive fair compensation for the value their inventions provide to their employer, Japanese patent law stands in stark contrast to its American counterpart. Japan’s fair compensation provisions have been on the books since 1959, but employee-inventors have only recently started to sue under these statutes.

Mr. Nakamura sued his former employer four years ago, seeking a share of the royalties from his invention after the company gave him an award of 20,000 yen, or less than $200, for his work. See the entire article here.

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Editor-in-Chief Barista Stephen Jenei is a patent attorney and Owner of Jenei LLC. When not serving up patent chat over a steaming cup of java, he's handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields. More info @ Jenei LLC

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